Are psychosocial smoking cessation interventions delivered in pregnancy equally effective? A systematic review, meta-analysis and equity analysis of moderation analyses in randomized controlled trials.

Tobacco smoking in pregnancy causes serious health problems for the developing fetus and mother. When used by non-pregnant smokers, pharmacotherapies (nicotine replacement therapy (NRT), bupropion, and varenicline) are effective for increasing smoking cessation, however their efficacy and safety in pregnancy remains unknown. Electronic cigarettes (ECs) are becoming widely used, but their efficacy and safety when used for smoking cessation in pregnancy are also unknown.To determine the efficacy and safety of smoking cessation pharmacotherapies and ECs used during pregnancy for smoking cessation in later pregnancy and after childbirth, and to determine adherence to smoking cessation pharmacotherapies and ECs for smoking cessation during pregnancy.We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (20 May 2019), trial registers, and grey literature, and checked references of retrieved studies.Randomised controlled trials (RCTs) conducted in pregnant women, comparing smoking cessation pharmacotherapy or EC use with either placebo or no pharmacotherapy/EC control. We excluded quasi-randomised, cross-over, and within-participant designs, and RCTs with additional intervention components not matched between trial arms.We followed standard Cochrane methods. The primary efficacy outcome was smoking cessation in later pregnancy; safety was assessed by 11 outcomes (principally birth outcomes) that indicated neonatal and infant well-being. We also collated data on adherence to trial treatments. We calculated the risk ratio (RR) or mean difference (MD) and the 95% confidence intervals (CI) for each outcome for each study, where possible. We grouped eligible studies according to the type of comparison. We carried out meta-analyses where appropriate.We included 11 trials that enrolled a total of 2412 pregnant women who smoked at enrolment, nine trials of NRT and two trials of bupropion as adjuncts to behavioural support, with comparable behavioural support provided in the control arms. No trials investigated varenicline or ECs. We assessed four trials as at low risk of bias overall. The overall certainty of the evidence was low across outcomes and comparisons as assessed using GRADE, with reductions in confidence due to risk of bias, imprecision, and inconsistency. Compared to placebo and non-placebo (behavioural support only) controls, there was low-certainty evidence that NRT increased the likelihood of smoking abstinence in later pregnancy (RR 1.37, 95% CI 1.08 to 1.74; I² = 34%, 9 studies, 2336 women). However, in subgroup analysis by comparator type, there was a subgroup difference between placebo-controlled and non-placebo controlled RCTs (test for subgroup differences P = 0.008). There was unclear evidence of an effect in placebo-controlled RCTs (RR 1.21, 95% CI 0.95 to 1.55; I² = 0%, 6 studies, 2063 women), whereas non-placebo-controlled trials showed clearer evidence of a benefit (RR 8.55, 95% CI 2.05 to 35.71; I² = 0%, 3 studies, 273 women). An additional subgroup analysis in which studies were grouped by the type of NRT used found no difference in the effectiveness of NRT in those using patches or fast-acting NRT (test for subgroup differences P = 0.08). There was no evidence of a difference between NRT and control groups in rates of miscarriage, stillbirth, premature birth, birthweight, low birthweight, admissions to neonatal intensive care, caesarean section, congenital abnormalities, or neonatal death. In one study infants born to women who had been randomised to NRT had higher rates of 'survival without developmental impairment' at two years of age compared to the placebo group. Non-serious adverse effects observed with NRT included headache, nausea, and local reactions (e.g. skin irritation from patches or foul taste from gum), but data could not be pooled. Adherence to NRT treatment regimens was generally low. We identified low-certainty evidence that there was no difference in smoking abstinence rates observed in later pregnancy in women using bupropion when compared to placebo control (RR 0.74, 95% CI 0.21 to 2.64; I² = 0%, 2 studies, 76 women). Evidence investigating the safety outcomes of bupropion use was sparse, but the existing evidence showed no difference between the bupropion and control group.NRT used for smoking cessation in pregnancy may increase smoking cessation rates in late pregnancy. However, this evidence is of low certainty, as the effect was not evident when potentially biased, non-placebo-controlled RCTs were excluded from the analysis. Future studies may therefore change this conclusion. We found no evidence that NRT has either positive or negative impacts on birth outcomes; however, the evidence for some of these outcomes was also judged to be of low certainty due to imprecision and inconsistency. We found no evidence that bupropion may be an effective aid for smoking cessation during pregnancy, and there was little evidence evaluating its safety in this population. Further research evidence on the efficacy and safety of pharmacotherapy and EC use for smoking cessation in pregnancy is needed, ideally from placebo-controlled RCTs that achieve higher adherence rates and that monitor infants' outcomes into childhood. Future RCTs of NRT should investigate higher doses than those tested in the studies included in this review.

Smoking in pregnancy is a substantial public health problem. When used by non-pregnant smokers, pharmacotherapies [nicotine replacement therapy (NRT), bupropion and varenicline] are effective treatments for smoking cessation, however, their efficacy and safety in pregnancy remains unknown. To determine the efficacy and safety of smoking cessation pharmacotherapies, including NRT, varenicline and bupropion (or any other medications) when used to support smoking cessation in pregnancy. We searched the Pregnancy and Childbirth Group's Trials Register (5 March 2012), checked references of retrieved studies and contacted authors in the field. Randomised controlled trials (RCTs) with designs that permit the independent effects of any type of NRT (e.g. patch, gum etc.) or any other pharmacotherapy on smoking cessation to be ascertained were eligible for inclusion. Trials must provide very similar (ideally identical) levels of behavioural support or cognitive behaviour therapy (CBT) to participants in active drug and comparator trial arms.The following RCT designs are considered acceptable.Placebo RCTs: any form of NRT or other pharmacotherapy, with or without behavioural support/CBT, or brief advice compared with placebo NRT and additional support of similar intensity.RCTs providing a comparison between i) behavioural support/CBT or brief advice and ii) any form of NRT or other pharmacotherapy added to behavioural support of similar (ideally identical) intensity.Parallel- or cluster-randomised design trials are eligible for inclusion. However, quasi-randomised, cross-over and within-participant designs are not eligible for inclusion due to the potential biases associated with these designs. Two review authors independently assessed trials for inclusion and risk of bias and extracted data. Two assessors independently extracted data and cross checked individual outcomes of this process to ensure accuracy. The primary efficacy outcome was smoking cessation in later pregnancy (in all but one trial, at or around delivery); safety was assessed by seven birth outcomes that indicated neonatal well being and we also collated data on adherence. Six trials of NRT enrolling 1745 pregnant smokers were included; we found no trials of varenicline or bupropion. No statistically significant difference was seen for smoking cessation in later pregnancy after using NRT as compared to control (risk ratio (RR) 1.33, 95% confidence interval (CI) 0.93 to 1.91, six studies, 1745 women). Subgroup analysis comparing placebo-RCTs with those which did not use placebos found that efficacy estimates for cessation varied with trial design (placebo RCTs, RR 1.20, 95% CI 0.93 to 1.56, four studies, 1524 women; non-placebo RCTs, RR 7.81, 95% CI 1.51 to 40.35, two studies, 221 women; P value for random-effects subgroup interaction test = 0.03). There were no statistically significant differences in rates of miscarriage, stillbirth, premature birth, birthweight, low birthweight, admissions to neonatal intensive care or neonatal death between NRT or control groups. Nicotine replacement therapy is the only pharmacotherapy for smoking cessation that has been tested in RCTs conducted in pregnancy. There is insufficient evidence to determine whether or not NRT is effective or safe when used to promote smoking cessation in pregnancy or to determine whether or not using NRT has positive or negative impacts on birth outcomes. Further research evidence of efficacy and safety is needed, ideally from placebo-controlled RCTs that investigate higher doses of NRT than were tested in the included studies.

Smoking in pregnancy is a public health problem. When used by non-pregnant smokers, pharmacotherapies (nicotine replacement therapy (NRT), bupropion and varenicline) are effective for smoking cessation, however, their efficacy and safety in pregnancy remains unknown. Electronic Nicotine Delivery Systems (ENDS), or e-cigarettes, are becoming widely used but their efficacy and safety when used for smoking cessation in pregnancy are also unknown. To determine the efficacy and safety of smoking cessation pharmacotherapies (including NRT, varenicline and bupropion), other medications, or ENDS when used for smoking cessation in pregnancy. We searched the Pregnancy and Childbirth Group's Trials Register (11 July 2015), checked references of retrieved studies, and contacted authors. Randomised controlled trials (RCTs) conducted in pregnant women with designs that permit the independent effects of any type of pharmacotherapy or ENDS on smoking cessation to be ascertained were eligible for inclusion.The following RCT designs are included.Placebo-RCTs: any form of NRT, other pharmacotherapy, or ENDS, with or without behavioural support/cognitive behaviour therapy (CBT), or brief advice, compared with an identical placebo and behavioural support of similar intensity.RCTs providing a comparison between i) any form of NRT, other pharmacotherapy, or ENDS added to behavioural support/CBT, or brief advice and ii) behavioural support of similar (ideally identical) intensity.Parallel- or cluster-randomised trials were eligible for inclusion. Quasi-randomised, cross-over and within-participant designs were not, due to the potential biases associated with these designs. Two review authors independently assessed trials for inclusion and risk of bias and also independently extracted data and cross checked individual outcomes of this process to ensure accuracy. The primary efficacy outcome was smoking cessation in later pregnancy (in all but one trial, at or around delivery); safety was assessed by 11 outcomes (principally birth outcomes) that indicated neonatal and infant well-being; and we also collated data on adherence with trial treatments. This review includes a total of nine trials which enrolled 2210 pregnant smokers: eight trials of NRT and one trial of bupropion as adjuncts to behavioural support/CBT. The risk of bias was generally low across trials with virtually all domains of the 'Risk of bias' assessment tool being satisfied for the majority of studies. We found no trials investigating varenicline or ENDS. Compared to placebo and non-placebo controls, there was a difference in smoking rates observed in later pregnancy favouring use of NRT (risk ratio (RR) 1.41, 95% confidence interval (CI) 1.03 to 1.93, eight studies, 2199 women). However, subgroup analysis of placebo-RCTs provided a lower RR in favour of NRT (RR 1.28, 95% CI 0.99 to 1.66, five studies, 1926 women), whereas within the two non-placebo RCTs there was a strong positive effect of NRT, (RR 8.51, 95% CI 2.05 to 35.28, three studies, 273 women; P value for random-effects subgroup interaction test = 0.01). There were no differences between NRT and control groups in rates of miscarriage, stillbirth, premature birth, birthweight, low birthweight, admissions to neonatal intensive care, caesarean section, congenital abnormalities or neonatal death. Compared to placebo group infants, at two years of age, infants born to women who had been randomised to NRT had higher rates of 'survival without developmental impairment' (one trial). Generally, adherence with trial NRT regimens was low. Non-serious side effects observed with NRT included headache, nausea and local reactions (e.g. skin irritation from patches or foul taste from gum), but these data could not be pooled. NRT used in pregnancy for smoking cessation increases smoking cessation rates measured in late pregnancy by approximately 40%. There is evidence, suggesting that when potentially-biased, non-placebo RCTs are excluded from analyses, NRT is no more effective than placebo. There is no evidence that NRT used for smoking cessation in pregnancy has either positive or negative impacts on birth outcomes. However, evidence from the only trial to have followed up infants after birth, suggests use of NRT promotes healthy developmental outcomes in infants. Further research evidence on NRT efficacy and safety is needed, ideally from placebo-controlled RCTs which achieve higher adherence rates and which monitor infants' outcomes into childhood. Accruing data suggests that it would be ethical for future RCTs to investigate higher doses of NRT than those tested in the included studies.

Although many women stop smoking in pregnancy, others continue, causing harm to maternal and child health. Smoking behaviour is influenced by many factors, including the role of women's significant others (SOs) and support from health-care professionals (HPs). To enhance understanding of the barriers to, and facilitators of, smoking cessation and the feasibility and acceptability of interventions to reach and support pregnant women to stop smoking. Four parts: (1) a description of interventions in the UK for smoking cessation in pregnancy; (2) three systematic reviews (syntheses) of qualitative research of women's, SOs' and HPs' views of smoking in pregnancy using meta-ethnography (interpretative approach for combining findings); (3) semistructured interviews with pregnant women, SOs and HPs, guided by the social-ecological framework (conceptualises behaviour as an outcome of individuals' interactions with environment); and (4) identification of new/improved interventions for future testing. Studies in reviews conducted in high-income countries. Qualitative research was conducted from October 2013 to December 2014 in two mixed urban/rural study sites: area A (Scotland) and area B (England). Thirty-eight studies (1100 pregnant women) in 42 papers, nine studies (150 partners) in 14 papers and eight studies described in nine papers (190 HPs) included in reviews. Forty-one interviews with pregnant women, 32 interviews with pregnant women's SOs and 28 individual/group interviews with 48 HPs were conducted. The perceived barriers to, and facilitators of, smoking cessation in pregnancy and the identification of potential new/modified interventions. Syntheses identified smoking-related perceptions and experiences for pregnant women and SOs that were fluid and context dependent with the capacity to help or hinder smoking cessation. Themes were analysed in accordance with the social-ecological framework levels. From the analysis of the interviews, the themes that were central to cessation in pregnancy at an individual level, and that reflected the findings from the reviews, were perception of risk to baby, self-efficacy, influence of close relationships and smoking as a way of coping with stress. Overall, pregnant smokers were faced with more barriers than facilitators. At an interpersonal level, partners' emotional and practical support, willingness to change smoking behaviour and role of smoking within relationships were important. Across the review and interviews of HPs, education to enhance knowledge and confidence in delivering information about smoking in pregnancy and the centrality of the client relationship, protection of which could be a factor in downplaying risks, were important. HPs acknowledged that they could best assist by providing support and understanding, and access to effective interventions, including an opt-out referral pathway to Stop Smoking Services, routine carbon monoxide screening, behavioural support and access to pharmacotherapy. Additional themes at community, organisational and societal levels were also identified. Limitations include a design grounded in qualitative studies, difficulties recruiting SOs, and local service configurations and recruitment processes that potentially skewed the sample. Perceptions and experiences of barriers to and facilitators of smoking cessation in pregnancy are fluid and context dependent. Effective interventions for smoking cessation in pregnancy should take account of the interplay between the individual, interpersonal and environmental aspects of women's lives. Research focus: removing barriers to support, improving HPs' capacity to offer accurate advice, and exploration of weight concerns and relapse prevention. Interventions focus: financial incentives, self-help and social network interventions. This study is registered as PROSPERO CRD42013004170. The National Institute for Health Research Health Technology Assessment programme.

To determine the efficacy and safety of nicotine replacement therapy (NRT) with or without behavioural support when used to support smoking cessation in pregnancy. A systematic review of randomized controlled trials (RCTs) in which NRT was used with or without behavioural support to promote smoking cessation; trials providing unequal behavioural support to different trial groups were excluded. self-reported smoking cessation in later pregnancy, validated where possible by biochemical measures with appropriate cut-points; infants' safety: mean and low birth weights (LBW), preterm birth, fetal demise and neonatal intensive care unit (NICU) admissions. Five trials, enrolling 695 pregnant, regular smokers were included in the review. The pooled risk ratio (RR) and 95% confidence Interval (CI) for smoking cessation in later pregnancy after using NRT was 1.63 (0.85, 3.14). Subgroup analysis comparing studies at lower risk of bias (placebo-RCTs) with those at higher risk of bias (non-placebo-RCTs) found that efficacy estimates varied with trial design [RR (95% CI) for cessation in placebo-RCTs 1.17 (0.83, 1.65) versus 7.81 (1.51, 40.35) for non-placebo-RCTs]. Five of the seven safety outcomes were more positive among infants born to women who had used NRT, but none of the observed differences between trial groups reached statistical significance. There is currently insufficient evidence to determine whether or not nicotine replacement therapy is effective or safe when used in pregnancy for smoking cessation; further research and, in particular, placebo-randomized controlled trials are required.

372. Does smoking cessation in pregnancy affect rate of gestational weight gain?

Key content A 2005 survey of new mothers in England revealed that the prevalence of smoking among pregnant women remains high. Smoking remains the single largest preventable cause of fetal and infant morbidity in the UK. Potential problems during pregnancy include ectopic pregnancy, miscarriage, placental complications, premature rupture of membranes, premature birth and fetal growth restriction. Counselling sessions are effective in pregnancy and lead to a reduction in the incidence of preterm birth and low birthweight. Nicotine replacement therapy can be considered in pregnant women under some circumstances, whilst current evidence suggests other pharmacological therapies are contraindicated. Learning objectives To understand the risks of smoking to fetal and child health. To understand epidemiological factors and implications for smoking cessation services. To become familiar with the recommended smoking cessation methods offered during pregnancy. Ethical issues Nicotine crosses the placenta and has been shown to cause a dose‐related rise in maternal blood pressure and heart rate. Some argue that use of nicotine replacement therapy unnecessarily exposes the fetus to health risks. Please cite this article as: Eastham R, Gosakan R. Smoking and smoking cessation in pregnancy. The Obstetrician & Gynaecologist 2010;12:103–109.

BackgroundMaternal smoking during pregnancy can lead to serious adverse health outcomes for both women and their infants. While smoking in pregnancy has declined over time, it remains consistently higher in women with lower socioeconomic circumstances. Furthermore, fewer women in this group will successfully quit during pregnancy.AimThis study explores the barriers to smoking cessation experienced by socially disadvantaged pregnant women and investigates how interactions with health providers can influence their smoking cessation journey.MethodsWomen (either pregnant or birthed in the previous 10 years, who smoked or quit smoking in pregnancy) were recruited from a metropolitan public hospital antenatal clinic in South Australia and community organisations in surrounding suburbs. Seventeen women participated in qualitative semi-structured small focus groups or interviews. The focus groups and interviews were recorded, transcribed and thematically analysed.FindingsFour interconnected themes were identified: 1) smoking embedded in women’s challenging lives and pregnancies, 2) cyclic isolation and marginalisation, 3) feeling disempowered, and 4) autonomy and self-determination. Themes 3 and 4 are characterised as being two sides of a single coin in that they coexist simultaneously and are inseparable. A key finding is a strong unanimous desire for smoking cessation in pregnancy but women felt they did not have the necessary support from health providers or confidence and self-efficacy to be successful.ConclusionWomen would like improvements to antenatal care that increase health practitioners’ understanding of the social and contextual healthcare barriers faced by women who smoke in pregnancy. They seek improved interventions from health providers to make informed choices about smoking cessation and would like women-centred care. Women feel that with greater support, more options for cessation strategies and consistency and encouragement from health providers they could be more successful at antenatal smoking cessation. If such changes were made, then South Australian practice could align more with best practice international guidelines for addressing smoking cessation in pregnancy, and potentially improve outcomes for women and their children.

INTRODUCTIONThis paper provides an up-to-date summary of the effects of smoking in pregnancy as well as challenges and best practices for supporting smoking cessation in maternity care settings.METHODSWe conducted a qualitative review of published peer reviewed and grey literature.RESULTSThere is strong evidence of the effects of maternal tobacco use and secondhand smoke exposure on adverse pregnancy outcomes. Tobacco use is the leading preventable cause of miscarriage, stillbirth and neonatal deaths, and evidence has shown that health effects extend into childhood. Women who smoke should be supported with quitting as early as possible in pregnancy and there are benefits of quitting before the 15th week of pregnancy. There are a variety of factors that are associated with tobacco use in pregnancy (socioeconomic status, nicotine addiction, unsupportive partner, stress, mental health illness etc.). Clinical-trial evidence has found counseling, when delivered in sufficient intensity, significantly increases cessation rates among pregnant women. There is evidence that the use of nicotine replacement therapy (NRT) may increase cessation rates, and, relative to continued smoking, the use of NRT is considered safer than continued smoking. The majority of women who smoke during pregnancy will require support throughout their pregnancy, delivered either by a trained maternity care provider or via referral to a specialized hospital or community quit-smoking service. The 5As (Ask, Advise, Assess, Assist, Arrange) approach is recommended for organizing screening and treatment in maternity care settings. Additionally, supporting smoking cessation in the postpartum period should also be a priority as relapse rates are high.CONCLUSIONSThere have been several recent updates to clinical practice regarding the treatment of tobacco use in pregnancy. It is important for the latest guidance to be put into practice, in all maternity care settings, in order to decrease rates of smoking in pregnancy and improve pregnancy outcomes.

BackgroundSmoking during pregnancy causes obstetric and fetal complications, and smoking cessation may have great benefits for the mother and the child. However, some pregnant women continue smoking even in pregnancy.ObjectiveTo review the literature addressing the prevalence of smoking during pregnancy, explore psychosocial factors associated with smoking, and review the evidence of psychosocial interventions for smoking cessation during pregnancy in recent years.Literature reviewComputerized Internet search results in PubMed for the years spanning from 2004 to 2014, as well as references cited in articles, were reviewed. A search for the keywords “smoking cessation pregnancy” and “intervention” and “clinical trials” yielded 52 citations. Thirty-five citations were identified as useful to this review for the evidence of psychosocial interventions for smoking cessation during pregnancy.ResultsThe prevalence of smoking during pregnancy differs by country, reflecting the countries’ social, cultural, and ethnic backgrounds. Women who had socioeconomic disadvantages, problems in their interpersonal relationships, higher stress, depression, less social support, and who engaged in health-risk behaviors were more prone to smoking during pregnancy. Psychosocial interventions, such as counseling, are effective methods for increasing smoking cessation.ConclusionSmokers may have various psychosocial problems in addition to health problems. It is important to understand each individual’s social situation or psychosocial characteristics, and a psychosocial intervention focused on the characteristics of the individual is required.

674 Effect of a best-practice alert on the rates of smoking cessation during pregnancy

In addition to the health risks that maternal tobacco smoke exposure in pregnancy poses to women, this is a cause of substantial fetal morbidity and mortality. In pregnancy, maternal tobacco smoke exposure can arise because women either smoke or are passively exposed to environmental tobacco smoke as a consequence of other's smoking. This article discusses the scope for clinicians to help reduce both types of tobacco smoke exposure in pregnancy, with a specific focus on available and effective interventions for smoking cessation by pregnant women. Behavioral support with smoking cessation is the only intervention that has been proven to encourage smoking cessation in pregnancy and reduces smoking rates in late pregnancy by 6 to 7%. There are physiological reasons to suspect that nicotine replacement therapy (NRT) will be less or (in)effective for smoking cessation in pregnancy when compared with its use by nonpregnant smokers. However, there are also strong theoretical reasons to suspect that NRT is likely to be safer than continued smoking in pregnancy. Consequently, this article reviews evidence for the safety and effectiveness of NRT when used for smoking cessation in pregnancy and recommendations concerning the use of NRT in pregnancy are presented.

Unsupported attempts to quit smoking during pregnancy have a low success rate. Chances of quitting successfully are higher with an interpersonal treatment program but there is low uptake of this in the United Kingdom. Delivering a pregnancy-specific treatment program digitally may provide an alternative treatment route. This study explored pregnant smokers' perceptions of barriers and facilitators to using digital cessation support, along with identifying modes of delivery and engagement enhancers. Semi-structured interviews were carried out with an ethnically and socioeconomically diverse sample of 25 participants with recent experience of attempting to quit smoking in pregnancy, aged 20-40, from the United Kingdom. An inductive thematic analysis approach was used. Digital smoking cessation support, particularly a smartphone app, for pregnancy was felt to overcome many barriers to engaging with interpersonal support, being viewed as more convenient, and nonjudgmental, providing better consistency of advice, and enhancing privacy and autonomy. However, some participants felt that removing access to a human could undermine a digital support package and reduce engagement. Popular engagement enhancers included self-monitoring (eg, digital recording of smoking; smartphone-linked carbon monoxide monitoring), online communities, and remote access to nicotine substitution options. Digital support was viewed as having potential as a stand-alone intervention or working in conjunction with standard interpersonal treatment. The findings support the investigation of a digital support package as both a stand-alone and adjunct to standard interpersonal cessation support in pregnancy to increase the proportion of pregnant smokers who make a supported quit attempt. In many countries like the United Kingdom, there are few smoking cessation options routinely available that provide effective support for smoking cessation in pregnancy. To maximize impact, health services need an effective range of strategies to engage with and support quit attempts made by all pregnant smokers, particularly as interpersonal support options are not often well used. Development of a pregnancy-specific digital support package for smoking cessation in pregnancy may represent a means to help address this gap.

Smoking in pregnancy and/or not breastfeeding have considerable negative health outcomes for mother and baby. To understand incentive mechanisms of action for smoking cessation in pregnancy and breastfeeding, develop a taxonomy and identify promising, acceptable and feasible interventions to inform trial design. Evidence syntheses, primary qualitative survey, and discrete choice experiment (DCE) research using multidisciplinary, mixed methods. Two mother-and-baby groups in disadvantaged areas collaborated throughout. UK. The qualitative study included 88 pregnant women/recent mothers/partners, 53 service providers, 24 experts/decision-makers and 63 conference attendees. The surveys included 1144 members of the general public and 497 health professionals. The DCE study included 320 women with a history of smoking. (1) Evidence syntheses: incentive effectiveness (including meta-analysis and effect size estimates), delivery processes, barriers to and facilitators of smoking cessation in pregnancy and/or breastfeeding, scoping review of incentives for lifestyle behaviours; (2) qualitative research: grounded theory to understand incentive mechanisms of action and a framework approach for trial design; (3) survey: multivariable ordered logit models; (4) DCE: conditional logit regression and the log-likelihood ratio test. Out of 1469 smoking cessation and 5408 breastfeeding multicomponent studies identified, 23 smoking cessation and 19 breastfeeding studies were included in the review. Vouchers contingent on biochemically proven smoking cessation in pregnancy were effective, with a relative risk of 2.58 (95% confidence interval 1.63 to 4.07) compared with non-contingent incentives for participation (four studies, 344 participants). Effects continued until 3 months post partum. Inconclusive effects were found for breastfeeding incentives compared with no/smaller incentives (13 studies) but provider commitment contracts for breastfeeding show promise. Intervention intensity is a possible confounder. The acceptability of seven promising incentives was mixed. Women (for vouchers) and those with a lower level of education (except for breastfeeding incentives) were more likely to disagree. Those aged ≤ 44 years and ethnic minority groups were more likely to agree. Agreement was greatest for a free breast pump and least for vouchers for breastfeeding. Universal incentives were preferred to those targeting low-income women. Initial daily text/telephone support, a quitting pal, vouchers for > £20.00 per month and values up to £80.00 increase the likelihood of smoking cessation. Doctors disagreed with provider incentives. A 'ladder' logic model emerged through data synthesis and had face validity with service users. It combined an incentive typology and behaviour change taxonomy. Autonomy and well-being matter. Personal difficulties, emotions, socialising and attitudes of others are challenges to climbing a metaphorical 'ladder' towards smoking cessation and breastfeeding. Incentive interventions provide opportunity 'rungs' to help, including regular skilled flexible support, a pal, setting goals, monitoring and outcome verification. Individually tailored and non-judgemental continuity of care can bolster women's capabilities to succeed. Rigid, prescriptive interventions placing the onus on women to behave 'healthily' risk them feeling pressurised and failing. To avoid 'losing face', women may disengage. Included studies were heterogeneous and of variable quality, limiting the assessment of incentive effectiveness. No cost-effectiveness data were reported. In surveys, selection bias and confounding are possible. The validity and utility of the ladder logic model requires evaluation with more diverse samples of the target population. Incentives provided with other tailored components show promise but reach is a concern. Formal evaluation is recommended. Collaborative service-user involvement is important. This study is registered as PROSPERO CRD42012001980. The National Institute for Health Research Health Technology Assessment programme.

Smoking cessation Through Optimization of clinical care in Pregnancy: the STOP pragmatic randomized controlled trial